KIDScore D3— 510(k) K182798

Substantially Equivalent

Vitrolife A/S

FDA 510(k) clearance K182798 for KIDScore D3, Substantially Equivalent on 2019-07-19. Applicant: Vitrolife A/S. Device class: 2.

Clearance details

Applicant: Vitrolife A/S
Product code: Code PBH
Device class: Class 2
Regulation: 21 CFR 884.6195
Advisory panel: Obstetrics/Gynecology
Date received: 2018-10-02
Decision date: 2019-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Viby J, DK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.